In an immediately effective guidance document entitled Compliance Policy for Combination Product Postmarketing Safety Reporting (here), the FDA is announcing that it will exercise enforcement discretion for certain safety reporting requirements outlined in the Combination Product Postmarketing Safety Reporting Final Rule issued on December 20, 2016 (81 FR 92603) and codified in 21 CFR […]
As I was reviewing the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here) as I do a few times a month, I came across a new footnote to the report. It reads: ++++ = FY19 Approval and Tentative Approval counts were updated in April 2019 to better reflect program output by […]
Publishing tomorrow, the FDA will announce that 28 ingredients that were considered in the June 30, 2016 proposed rule were given the boot while further consideration of three ingredients (benzalkonium chloride, alcohol (also referred to as ethanol or ethyl alcohol), and isopropyl alcohol) were deferred until the firms had more time to conduct appropriate studies […]
March 2019 actually saw 89 full approvals and 17 tentative approvals for 106 approval actions (our predictions were off by one). This is another good month for ANDA approvals, but it is also a month that saw the largest number of ANDA submission for FY 2019 at 118. We believe this corresponds to the end […]
As the FDA and industry prepare for Dr. Gottlieb’s departure from the FDA tomorrow, he and Deputy Commissioner Anna Abram issued a statement (here) on the FDA’s 2019 priorities to improve the quality of compounded drugs. As the statement notes, compounded drug products are not FDA-approved and, thus, can pose a serious threat to the […]
The OGD had what appears to be another good month, fully approving eighty-eight ANDAs and tentatively approving seventeen ANDAs for a total of 105 approval actions. While a few stragglers may still be lurking and not yet listed on the FDA All Approvals page (here), it looks like a good and productive month for the […]
(Westbury, NY – April 2, 2019) Fran Zipp, President and CEO of Lachman Consultants, Inc. a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, today announced that Mary Oates has joined the firm as Vice President of Compliance Services. In her role, Oates will lead the expert team that […]
In the not-too-distant past (April 2015), the FDA held a public hearing on potential changes to the enforcement policies and the regulatory approach associated with the marketing of homeopathic drug products. The FDA indicated that it has not had a comprehensive review of the enforcement policies related to these products to reflect changes in […]
The 15 approvals for the generic of Cialis come on the day of the expirations of the 180-day exclusivity enjoyed by the first-to-file applicants. Assuring that the ANDAs gain approval on the first legally possible date that they can be approved means that the price will go down and, when 15 ANDAs receive approval, the […]
This morning the FDA released a guidance document entitled Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling (here) which provides direction to firms that are developing labeling for pediatric patients based on findings of required or literature studies or data that are either positive, negative or inconclusive. The guidance goes on to […]
